Analyte monitoring system with audible feedback

ABSTRACT

Described here are devices, systems, and methods for analyte measurement. The analyte measurement devices and systems may be configured to produce a prompt that may convey information, instructions and/or encouragement to a user. In some variations, analyte measurement devices may be configured to change a prompt based on the replacement or addition of components of/to the device. In some instances, a prompt may be an auditory prompt and/or a visual prompt. In some variations, a system may comprise an analyte measurement device comprising a housing, a speaker, and a control unit. The housing may comprise a releasable housing portion comprising an identifier that is associated with a prompt. In some variations, a system may comprise an analyte measurement device and a skin that may releasably attach to the analyte measurement device and may comprise an identifier that is associated with a prompt.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 61/838,171, filed on Jun. 21, 2013, which is hereby incorporated byreference in its entirety.

FIELD

The present invention relates to devices and methods for monitoring ananalyte in a fluid sample (e.g. blood glucose) and providing visualand/or auditory feedback to a user of the devices.

BACKGROUND

Diabetes is a widespread condition, affecting millions worldwide. In theUnited States alone, an estimated 23.6 million people, or 7.8% of thepopulation, have the condition. Diabetes accounts for an estimated $174billion annually in direct and indirect medical costs. Depending on thetype (Type 1, Type 2, and the like), diabetes may be associated with oneor more symptoms such as fatigue, blurred vision, and unexplained weightloss, and may further be associated with one more complications such ashypoglycemia, hyperglycemia, ketoacidosis, neuropathy, and nephropathy.

To help delay or prevent these undesirable complications, it may benecessary for people with diabetes to monitor one or more blood analytelevels, such as blood glucose. Glucose testing allows a patient toensure that his or her blood glucose is at a safe level, which in turnmay help monitor the effectiveness of diet, medication, and exercise incontrolling the patient's diabetes, and may also help reduce the risk ofdeveloping one or more diabetes-related conditions (e.g., blindness,kidney damage and nerve damage). Many of the currently available glucosemeters, however, require numerous components and complicated steps tocomplete a test, and may result in a frustrating or otherwise negativeuser experience (which may reduce the likelihood of user compliance). Assuch, it may be desirable to produce safe and effective analyteconcentration meters that may make sampling discrete and easier for theuser.

BRIEF SUMMARY

Described here are analyte measurement devices and systems for providingfeedback to a user. In some variations, an analyte measurement devicemay be configured to produce a plurality of auditory prompts to a user,and these prompts may convey information, instructions, and/orencouragement to a user. In some variations, the analyte measurementdevice may be able to change a set of auditory prompts outputted by theanalyte measurement device. In some of these variations, a system maycomprise an analyte measurement device comprising a housing, a speakerand a control unit. In these variations, the housing may comprise areleasable housing portion and the releasable housing portion maycomprise an auditory identifier that is associated with an auditoryprompt set. The control unit may be configured to detect the auditoryidentifier, set the auditory prompt set associated with the detectedauditory identifier as an active prompt set, and instruct the speaker tooutput at least one auditory prompt from the active prompt set. In somevariations, the control unit may comprise a processor and/or a memoryunit.

In some variations the system may further comprise a plurality ofreleasable housing portions. In some of these variations, each of thereleasable housing portions may be associated with an auditory promptset comprising at least one auditory prompt that differs from at leastone auditory prompt associated with the other releasable housingportions of the plurality of releasable housing portions. In someembodiments, the auditory prompt set associated with a releasablehousing portion may be stored on the memory unit. In other embodiments,the auditory prompt set associated with the releasable housing portionmay be stored on the releasable housing portion or on a server. Thecontrol unit may also comprise a speech unit and instructing the speakerto output at least one auditory prompt from the active prompt set maycomprise transmitting a signal associated with the at least one auditoryprompt from the speech unit to the speaker. In some variations, theanalyte measurement devices described here may further comprise adisplay and/or a microphone. In some embodiments, the analytemeasurement device may be an integrated meter. In some variations, thesystem may further comprise a cartridge.

In some embodiments, a system may comprise an analyte measurement devicecomprising a housing, a speaker, a control unit, and a skin. In thesevariations, the skin may be configured to releasably attach to thehousing and may comprise an auditory identifier that may be associatedwith an auditory prompt set. The control unit may be configured todetect the auditory identifier, set the auditory prompt set associatedwith the detected auditory identifier as an active prompt set, andinstruct the speaker to output at least one auditory prompt from theactive prompt set. In some variations, the control unit may comprise aprocessor and/or a memory unit.

In some variations the system may further comprise a plurality of skins.In some of these variations, each skin may be associated with anauditory prompt set comprising at least one auditory prompt that differsfrom at least one auditory prompt associated with the other skins of theplurality of skins. In some embodiments, the auditory prompt setassociated with a skin may be stored on the memory unit. In otherembodiments, the auditory prompt set associated with the skin may bestored on the skin or on a server. The control unit may also comprise aspeech unit and instructing the speaker to output at least one auditoryprompt from the active prompt set may comprise transmitting a signalassociated with the at least one auditory prompt from the speech unit tothe speaker. In some variations, the analyte measurement devicesdescribed here may further comprise a display and/or a microphone. Insome embodiments, the analyte measurement device may be an integratedmeter. In some variations, the system may further comprise a cartridge.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B depict a front view, and a perspective bottom view,respectively of a variation of an analyte measurement device asdescribed here. FIG. 1C depicts a perspective view of a cartridge thatmay be used with an analyte measurement device described here.

FIG. 2A depicts a perspective view of a cartridge. FIG. 2B depicts anexploded view of a sampling arrangement contained in a cartridge.

FIGS. 3A and 3B depict block diagrams of variations of the analytemeasurement devices described here.

FIG. 4 depicts a schematic representation of a server system.

FIGS. 5A and 5B depict front views of a variation of the analytemeasurement devices described here.

FIGS. 6A and 6B depict front views of a variation of the analytemeasurement devices described here.

FIG. 7A depicts a perspective view of a variation of an analytemeasurement device described here comprising an additional housingportion. FIG. 7B depicts a back view of a variation of an analytemeasurement device comprising a removable housing portion. FIG. 7Cdepicts a back view of an analyte measurement device with the back coverremoved.

FIGS. 8A and 8B depict a front view and perspective view respectively ofa variation of the analyte measurement devices described here with askin. FIGS. 8C and 8D depict top perspective views of a variation of theanalyte measurement devices described here without a skin, and with askin, respectively.

DETAILED DESCRIPTION

Described here are analyte measurement systems and devices, and methodsof using the same. Generally, the devices described here comprise ananalyte measurement device configured to audibly communicate with auser. In some embodiments, the analyte measurement devices audiblyand/or visually communicate with the user by outputting prompts orreceiving commands. In some variations, the analyte measurement devicesmay be configured with an auditory and/or visual output based on one ormore removable components of the analyte measurement device. In thesevariations, the systems may comprise an analyte measurement device andone or more removable components (e.g., a removable portion of ahousing, a cartridge, a skin, or the like).

Analyte Measurement Devices

Generally, the analyte measurement devices described here are configuredto perform one or more steps of an analyte measurement operation inwhich the concentration of one or more analytes in a fluid sample ismeasured. For example, an analyte measurement device may be configuredto perform one or more of the following operations: collect a fluidsample from a sampling site, transport the fluid sample to an analysissite, and analyze the fluid sample. When the analyte measurement deviceis configured to collect a fluid sample from a sampling site, the devicemay be configured to collect a fluid sample from any suitable samplingsite. Examples of suitable sampling sites include, but are not limitedto, one or more body sites (e.g., fingers, toes, other skin surfaces, orthe like) or one or more artificial containers (e.g., a vial holding acontrol solution or a body fluid sample). The fluid sample may compriseany suitable fluid, such as, for example, one or more solutions (e.g., acontrol solution), mixtures, body fluids (e.g., blood, saliva, or thelike), combinations thereof and the like. Analysis of a fluid sample mayinclude determining the concentration of one or more analytes in thesample, such as one or more hormones, proteins, enzymes, toxins, drugs,other molecules, or the like. In some variations, the analytemeasurement devices described here may be configured to measure theglucose concentration of one or more blood samples or otherglucose-containing solutions.

In some variations, an analyte measurement device as described here maybe fully integrated, in that the device may contain all of thecomponents necessary for collecting, transporting, and analyzing a fluidsample. For example, the systems described here may comprise one or moreof the devices described in U.S. patent application Ser. No. 13/566,886,filed Aug. 3, 2012 and titled “DEVICES AND METHODS FOR BODY FLUIDSAMPLING AND ANALYSIS,” U.S. Pat. No. 7,004,928, filed Apr. 23, 2002 andtitled “AUTONOMOUS, AMBULATORY ANALYTE MONITOR OR DRUG DELIVERY DEVICE,”and U.S. Pat. No. 8,012,103 and titled “CATALYSTS FOR BODY FLUID SAMPLEEXTRACTION,” the contents of each of which are hereby incorporated byreference in their entirety. It should also be appreciated that theanalyte measurement devices described here may be configured to performonly a subset of the collecting, transporting, and analyzing operationsassociated with analysis of a fluid sample.

For example, the analyte measurement device may comprise a fullyintegrated meter. The meter may comprise a meter housing and one or morecartridges, which will be described in more detail below. In somevariations, the meter may be configured to collect and analyze aplurality of fluid samples. For example, in some variations, a cartridgemay comprise one or more cells, some or all of which may contain one ormore sampling arrangements for collecting a fluid sample, as describedin more detail below. The meter may be further configured to audibly,visually or otherwise provide one or more results from the sampleanalysis. Some portions of the meter may be reusable, while otherportions of the meter may be disposable. For example, in somevariations, the meter housing is reusable while the cartridge isdisposable. In these variations, new cartridges may be inserted into orotherwise engage with a meter housing to conduct a new series of tests.In other variations, both the meter housing and the cartridge may bedisposable.

FIGS. 1A-1C show an illustrative variation of an exemplary integratedmeter (100). Specifically, FIGS. 1A and 1B show a front view and abottom perspective view, respectively, of a meter housing (118), whileFIG. 1C shows a perspective view of the cartridge (102). While shown inFIG. 1C as being stored in a sealed or sealable pouch (116), thecartridge (102) may be stored in any suitable container, and may beremoved prior to use. As shown in FIGS. 1A and 1B, the meter housing(118) may comprise a door (104) with a cartridge-engagement projection(105), a cartridge-receiving chamber (106) or cavity, a cartridgeejection button (113), a display (108), buttons (110), a port (112), anda tower (114). The meter need not include each of these features, and itshould be appreciated that the meter may comprise any combination ofthese features. The meter (100) may further comprise one or more imagingsystems (not shown), and internal mechanisms or components (e.g.,memory, circuitry, actuators, batteries, vacuum pumps, sensors,combinations thereof, etc.) for operating the meter and/or facilitatinga testing procedure.

A cover or door (104) may be opened to reveal a cartridge-receivingchamber (106), as shown in FIG. 1B. A cartridge (102) may be placedinside of cartridge-receiving chamber (106), and the door (104) may beclosed to temporarily enclose the cartridge (102) within the meterhousing (118). When placed inside of the meter housing, one or moreportions of the cartridge (102) may engage one or more components of themeter housing (118). In some variations, the meter housing (118) maycomprise one or more features that may facilitate self-alignment of thecartridge (102) as it is placed in the cartridge-receiving chamber(106). For example, in some variations the cartridge (102) may comprisea recess (not shown). When the cartridge (102) is placed inside of thecartridge-receiving chamber (106), a portion of the tower (114) may fitwithin or otherwise engage the recess of the cartridge (102). Thisengagement may help to hold the cartridge (102) in place relative tometer housing (118). Conversely, in some variations, the cartridge (102)may comprise one or more projections (not shown) that may engage one ormore recesses (not shown) in the cartridge-receiving chamber (106) orother portion of the meter housing (118). Additionally or alternatively,one or more magnets may hold the cartridge in place relative to themeter housing. A cartridge need not be placed inside of a meter housing(e.g., via a cartridge-receiving chamber) to engage the meter housing.For example, in some variations, a cartridge may attach to or otherwiseengage one or more external surfaces of a meter housing.

Any suitable cartridge may be used with the meters. For example, in somevariations, the meter may comprise one or more of the cartridgesdescribed in U.S. patent application Ser. No. 11/529,614, titled“MULTI-SITE BODY FLUID SAMPLING AND ANALYSIS CARTRIDGE,” and U.S. Pat.No. 8,231,832, titled “ANALYTE CONCENTRATION DETECTION DEVICES ANDMETHODS,” the contents of each of which is hereby incorporated byreference in its entirety. A suitable variation of a cartridge that maybe used with the meter described above is illustrated in FIG. 2A. Asshown there, the cartridge (200) may house or otherwise hold one or moresampling arrangements (202). These sampling arrangements (202) maycomprise one or more components for collecting, transporting, and/orreacting with a fluid sample. For example, in some variations, thesampling arrangement may comprise a penetration member for piecing,penetrating or otherwise puncturing a sampling site during a testingprocedure. In variations where the cartridge (200) comprises a pluralityof sampling arrangements (202), each sampling arrangement (202) may beutilized to conduct a separate test on a different fluid sample. Thesampling arrangement may further comprise a hub or other structure formoving the penetration member relative to the cartridge. Additionally,the sampling arrangement (202) may comprise a quantification member (notshown), which may react with the fluid sample to produce a measurableresponse (e.g., an electrochemical or photometric response) that may beindicative of one or more properties of the fluid sample. In variationswhere the cartridge (200) is configured to be disposable, new cartridgesmay be swapped in to provide unused (e.g., unfired) samplingarrangements. Any reactions that occur between sampling arrangement andthe fluid sample may be quantified or measured by one or more portionsof the cartridge or the meter housing (e.g., an imaging system). In somevariations, one or more portions of the cartridge may be reusable. Forexample, a cartridge containing one or more unused sampling arrangementsmay be loaded into the cartridge to allow the meter to conductadditional testing procedures. While the meter (100) is discussed aboveas having a cartridge, the meter need not.

FIG. 2B depicts an exploded view of a sampling arrangement (202). Shownthere are a hub (204), a skin penetration member (206), a quantificationmember (208) (e.g., a pad), a cap (210), and a spring (212). The hub(204) may comprise a latch (214), pivot bars (216), and a micropatternedsurface (218). In this variation, the hub (204) may hold the skinpenetration member (206) such that an interior bore (220) of the skinpenetration member (206) is in fluid communication with themicropatterned surface (218). The quantification member (208) may beplaced on the micropatterned surface (218) and a cap (210) may be placedat least partially over the quantification member (208) to hold thequantification member (208) in place against the micropatterned surface(218). The cap (210) may comprise an aperture (222) through which thequantification member (208) may be viewed by an imaging system (e.g.,light source and detector) to determine the concentration of an analytein a sample. While spring (212) is depicted as a torsional spring, anymechanism capable of moving the skin penetration member may be utilized(e.g., linear spring, leaf spring, conical spring, mechanically-drivenarm, sliding actuator etc.).

The meter housing (118) may be configured to house a speaker and/or amicrophone (not shown) and a control unit (not shown), although itshould be appreciated that the speaker, microphone, and/or control unitmay in some instances be partially housed in the housing (118), may beexternally attached to the housing (118), or may be part of a separatedevice (i.e., headphones, cellular phone, computer, tablet, etc.) thatcommunicates with the meter either wirelessly or through a wiredconnection. As depicted in FIG. 1A, the meter housing (118) mayadditionally comprise a display (108) (e.g., for visually providinginformation to a user), buttons (110) (e.g., for powering on/off thedevice, inputting information into the device, etc.) and a port (112)(e.g., through which a fluid sample may be collected), such as thosedescribed in U.S. patent application Ser. No. 13/566,886, which waspreviously incorporated by reference in its entirety. Additionally oralternatively, the meter (100) may in some instances further compriseone or more imaging systems (not shown), and internal mechanisms orcomponents (e.g., memory, circuitry, actuators, batteries, vacuum pumps,sensors, combinations thereof, etc.) for operating the meter (100)and/or facilitating testing of a fluid sample The analyte measurementdevices described here need not include each of these features, andvariations of these devices may comprise any combination of thesefeatures.

As mentioned above, the analyte measurement devices described here aregenerally configured to provide some form of feedback (auditory, visual,tactile, etc.) to a user. Generally, the analyte measurement devicesdescribed here may comprise a control unit comprising a memory unit(which can include one or more computer-readable storage mediums), oneor more processors (CPU's), and a speech unit. The one or moreprocessors may execute various software programs and/or sets ofinstructions stored in the memory unit to perform various functions forthe device and to process data. In some examples, the memory unit,processor and speech unit may be implemented on a single chip. In otherexamples, they can be implemented on separate chips. Depending on thedesired functionality of the device, the device may further comprise anynumber of components, including but not limited to, circuitry of anykind (e.g., RF circuitry, audio circuitry, display circuitry, lightingcircuitry, integrated circuits, etc.), a speaker, a microphone, atactile output generator (e.g., a vibrational element), a display(including a touch-sensitive display system), one or more externalports, etc. The device may include all of the above listed components,or any sub combination of the components. Additionally, the variouscomponents described may be implemented across two or more devices(e.g., an analyte measurement device and a cellular phone), of which oneor more may include a home computer, or a remote server accessed by alocal area network or by the internet. In an example where two or moredevices are used, the devices can communicate with each other tofacilitate operation of the devices. The communication may or may not beencrypted.

The analyte measurement devices may also be configured to receive,compile, store, and access data. In some variations, the analytemeasurement device may be configured to access and/or receive data fromdifferent sources. The analyte measurement device may be configured toreceive data directly entered by a user and/or it may be configured toreceive data from separate devices (e.g. a cellular phone, tablet,computer, etc.) and/or from a storage medium (flash drive, memory card,etc.). The analyte measurement device may receive the data through anetwork connection, as discussed in more detail below, or through aphysical connection with the device or storage medium (e.g. through USBor any other type of port). The analyte measurement device may compilethe data using a processor and may store the data on a memory unitwithin the access device, or it may transmit the data to an externalserver for storage. Furthermore, the analyte measurement device maylater access the stored data using the processor.

The analyte measurement device may be configured to receive varioustypes of data. For example, the analyte measurement device may beconfigured to receive a user's personal data (e.g., gender, weight,birthday, age, height, diagnosis date, anniversary date using thedevice, etc.), a user's testing history (e.g., number of testscompleted, time each test was completed, date each test was completed,pre or post prandial test markings, how many tests a user has completedconsecutively, etc.), a user's results history (e.g., glucose level attime test was taken), a user's diet information (e.g., what a user hadto eat each day, number of alcoholic beverages, amount of carbohydratesconsumed, etc.), a user's exercise information (e.g., if a userexercised, when the user exercised, duration of exercise, what type ofexercise the user completed (e.g. biking, swimming, running, etc.),exertion level of the exercise (e.g., low, medium, high), a user's heartrate during exercise, etc.), general health information of othersimilarly situated patients (e.g., typical test results for a similaruser at a similar time of day, average of test results for a similaruser after exercise, etc.), or any other information that may berelevant to a user's treatment. In some variations, the analytemeasurement device may be configured to create, receive, and/or storeuser profiles. A user profile may contain any of the user specificinformation previously described. Additionally, the analyte measurementdevice may be configured to receive general information useful indetermining when testing occurs (e.g., time of day, date, location) asis described in more detail in U.S. patent application Ser. No.12/457,332, titled “MEDICAL DIAGNOSTIC DEVICES AND METHODS,” the contentof which is hereby incorporated by reference in its entirety. While theabove mentioned information may be received by the analyte measurementdevice, in some embodiments the analyte measurement device may beconfigured to calculate any of the above data from information it hasreceived using software stored on the device itself, or externally.

In some embodiments, the analyte measurement device may be configured toidentify patterns in user behavior, use the identified patterns topredict future user behavior, and provide prompts to the user relatingto the identified patterns, as is described in more detail in U.S.patent application Ser. No. 12/457,332, titled “MEDICAL DIAGNOSTICDEVICES AND METHODS,” which was previously incorporated by reference inits entirety. In some instances, the analyte measurement device may usethe patterns to help warn about, or prevent the occurrence of one ormore glucose events. A glucose event may occur any time a user's glucoseis above or below an expected level or is outside a specified range. Insome embodiments, a glucose event may be a hypoglycemic event or ahyperglycemic event. In some variations, the analyte measurement devicemay be configured to compare the user's personal data, testing history,diet information, exercise information, or any other relevantinformation, to a user's historical data (e.g. prior test data, user'shistorical trends, etc.), data preloaded onto the analyte measurementdevice that has been compiled from external sources (e.g. medicalstudies), or data received from a separate device (e.g., historical dataor data compiled from external sources), as is described in more detailbelow. In some instances, the warning or notification may includeinstructions to perform a test, seek medical attention, and/or to eat ordrink something.

The analyte measurement device may be configured to calculate thelikelihood of a glucose event based on data it has received and mayprovide an alert or prompt to a user based on its calculation. In somevariations, the method of alerting a user of a glucose event maycomprise receiving user information, identifying the user information asa stimulus for a glucose event (e.g., exercise, alcohol consumption,sugar consumption, heavy meals, etc.), calculating a likelihood ofoccurrence of the glucose event, determining when the glucose event willoccur, and alerting or prompting the user in advance of the glucoseevent based on the determination of when the glucose event will occur.The reporting of a risk, if any, may be based upon whether the riskcalculation meets or exceeds a certain threshold, or certain criteria.

For example, some users may experience a higher risk of a glucose eventafter intense exercise (e.g., high intensity for 60 minutes, moderateintensity for 90 minutes, low intensity for 120 minutes) or afterconsuming a certain number or amount of alcoholic beverages (e.g. 5glasses of wine, 4.5 ounces of vodka, etc.). The user may inputinformation about his exercise regimen or alcohol consumption into theanalyte measurement device or a separate device communicating with theanalyte measurement device. The analyte measurement device may identifythe information as a stimulus for a glucose event based on datapreloaded onto the analyte measurement device, data received from aseparate device, and/or a user's historical data, and may mark theinformation as a stimulus. The analyte measurement device may comparethe user's information to the preloaded, received, and/or historicaldata to calculate a likelihood of occurrence of the glucose event. Ifthere is a high probability that a glucose event may occur, the analytemeasurement device may use the preloaded, received, and/or historicaldata to determine when the event is likely to occur (e.g., 12 hoursafter exercising, 4 hours after consuming alcohol, etc.), and may alertor prompt the user at an appropriate time (e.g., 11 hours afterexercising, 3 hours and 45 minutes after consuming alcohol, etc.), as isdescribed in more detail below.

In some embodiments, calculating the likelihood of the occurrence of aglucose event may comprise comparing the user's information with theuser's historical information (e.g. prior test result, historicalaverage, historical trend, predictive value, etc.) assigning aprobability of a glucose event occurring based on the comparison,determining if the probability is larger than a threshold value, and ifso, determining that alerting or prompting a user is necessary. In otherembodiments, calculating the likelihood of the occurrence of a glucoseevent may comprise comparing the user's information with the healthinformation of other patients, for example, similarly situated patients(e.g., patients of similar age, weight, patterns, etc.). In yet otherembodiments, calculating the likelihood of the occurrence of a glucoseevent may comprise comparing the user's information with both the user'shistorical information and the health information of similarly situatedpatients, assigning a probability to each comparison, and averaging theprobabilities. While a simple average is described, a more complexweighting scheme may be utilized. For example, in some embodiments, thecomparison of the user's information with the user's historicalinformation may be weighted more heavily than the comparison of theuser's information with the health information of similarly situatedpatients. In still other variations, calculating the likelihood of theoccurrence of a glucose event may comprise comparing many differentfactors (e.g., duration of exercise, intensity of exercise, last meal,and age) with the same factors in multiple data sets (e.g., historicaldata, similarly situated patient data, etc.) and assigning each factor adifferent weight to determine a final probability.

In some examples, determining when the glucose event will occur may alsocomprise comparing the user's information with the user's historicalinformation or the health information of similarly situated patients.This comparison may provide information about how much time may elapsebetween the stimulus and the glucose event (i.e. a response time). Theresponse times may also be averaged or assigned weights.

FIGS. 3A and 3B show block diagrams of variations of another analytemeasurement device (300). As shown in FIG. 3A, the analyte measurementdevice (300) may comprise a speaker (302) configured to produce a soundoutput, and a control unit (304) configured to control the sound outputof the speaker (302). The control unit (304) may include electronicscapable of outputting audio signals to the speaker (302). For example,in the variations shown in FIGS. 3A and 3B, the control unit (304) maycomprise a processor (306), a speech unit (308), and a memory unit(310). The memory unit (310) can include high-speed random access memoryand non-volatile memory, such as one or more magnetic disk storagedevices, flash memory devices, or other non-volatile solid-state memorydevices. In the variation depicted in FIG. 3A, the memory unit (310) maybe configured to store data relating to a plurality of sound outputs forthe speaker (302), the processor (306) may be configured to select aspecific sound output from the plurality of sound outputs, and thespeech unit (308) may be configured to convert the data relating to thesound output into a signal that may be transmitted to the speaker (302),or a wireless audio transmitter, e.g. IR, Bluetooth, wireless USBprotocol, WiFi IEEE 802.11x protocols, 2.4 GHz or 5 GHz transmissions.The speaker (302) may then convert the signal to human-audible soundwaves. The data relating to the sound output may comprise any audiofile, for example, sample sound files, a library of sounds, recordeddata files, sound files that may be used together to form compositespeech, or any other type of audible indicia file. In some variations,the analyte measurement device (300) may include a headset jack insteadof, or in addition to, a speaker (302). The headset jack may provide aninterface between the speech unit (308) and removable audio outputdevices, such as output-only headphones, an external speaker, or aheadset with both an output (e.g. a headphone for one or both ears) andan input (e.g., a microphone.)

In some variations, the analyte measurement device (300) may alsocomprise a vibrational element (314), for example, a vibrating motor orthe like, such that the analyte measurement device may provide tactilefeedback to a user. The tactile feedback may be provided to the userthrough the housing (118), the port (112), or any other component of thedevice capable of transmitting vibration. In this variation, the memoryunit (310) may be configured to store data relating to a plurality ofvibrational patterns, and the processor (306) may be configured toselect a specific pattern from the plurality of vibrational patterns andcommunicate with an actuator configured to activate and deactivate thevibrational element.

In some variations, the analyte measurement device (300) may also beconfigured to produce a visual output to communicate information to auser. As shown in FIG. 3A, the analyte measurement device (300) maycomprise a display (318) configured to produce a visual output, and acontrol unit (304) configured to control the visual output of thedisplay (318). The display (318) may use LCD (liquid crystal display)technology, LPD (light emitting polymer display) technology, and/or LED(light emitting diode) or OLED (organic LED) technology, although otherdisplay technologies can be used in other examples. As mentioned above,the display (318) may also use touch sensing technology, including butnot limited to, capacitive, resistive, infrared and surface acousticwave technologies, other proximity sensor arrays, or other elements fordetermining one or more points of contact with the display (318), suchthat the display (318) may also act as a touchscreen. The control unit(304) may include electronics capable of outputting visual signals tothe display (318). In the variation depicted in FIGS. 3A and 3B, thememory unit (310) may be configured to store data relating to aplurality of visual outputs for the display (318) and the processor(306) may be configured to select a specific visual output from theplurality of visual outputs and communicate with the display (318) suchthat the selected specific visual output appears on the display (318).While the display (318) is depicted in FIGS. 3A and 3B as an integrateddisplay, the analyte measurement device (300) may not comprise a display(318) and a separate interface may be used to display information (e.g.,a cellular phone, computer, tablet, etc.).

In some embodiments, the analyte measurement device (300) may also beconfigured to detect and respond to audible commands. As depicted inFIG. 3B, the analyte measurement device (300) may comprise a microphone(312) configured to detect sound, and a control unit (304) configured tointerpret and control how the detected sound is utilized by the analytemeasurement device (300). The control unit (304) may include electronicscapable of detecting sound and converting it into instructions for thedevice. For example, the control unit (304) may comprise a processor(306), a speech unit (308), and a memory unit (310). The microphone(312) may be configured to detect an audible command and convert it intoa data signal, the speech unit (308) may be configured to convert thedata signal into instructional data for the analyte measurement device,the memory unit (312) may be configured to store instructional datarelating to a plurality of instructions, and the processor (306) may beconfigured to select a specific instruction from a plurality ofinstructions stored on the memory unit (312) and implement it. In someembodiments, the analyte measurement device (300) may include a headsetjack instead of, or in addition to, a microphone (310). The headset jackmay provide an interface between the speech unit (308) and removableaudio input devices, such as an external microphone or a headset withboth an output (e.g. a headphone for one or both ears) and an input(e.g., a microphone).

In some variations, the analyte measurement device may communicate withand provide auditory, visual, or other information to a separate userdevice. For example, FIG. 3B depicts a variation of an analytemeasurement device (300) comprising RF (radio frequency) circuitry(316). The RF circuitry (316) may receive and send RF signals. The RFcircuitry (316) may convert electrical signals to/from electromagneticsignals and communicate with communications networks and othercommunications devices via the electromagnetic signals. The RF circuitry(316) may comprise well-known circuitry for performing these functions,including but not limited to an antenna system, an RF transceiver, oneor more amplifiers, a tuner, one or more oscillators, a digital signalprocessor, a CODEC chipset, a subscriber identity module (SIM) card,memory, and so forth. The RF circuitry (316) may communicate withnetworks, such as the network (406) illustrated in the exemplarycommunication system (400) depicted in FIG. 4.

FIG. 4 depicts an exemplary system (400) for sending and receivingauditory, visual, or other information between user devices (402, 404).The first user device (402) may be an analyte measurement device, suchas the analyte measurement device (300) depicted in FIGS. 3A-3B, and thesecond user device (404) may include any of a variety of devices, suchas a cellular telephone (e.g., smartphone), tablet computer, laptopcomputer, desktop computer, portable media player, wearable digitaldevice (e.g., digital glasses, wristband, wristwatch, brooch, armbands,etc.), television, set top box (e.g., cable box, video player, videostreaming device, etc.), gaming system, or the like. While two userdevices (402, 404) are depicted, any number of user devices (402, 404)could be included in the system (400).

The user devices (402, 404) may transmit data (e.g. user data, testdata, audible prompts, visual prompts, etc.) to the server system (408)through the network (406). The network (406) may include any of avariety of networks, such as a cellular telephone network, WiFi network,wide area network, local area network, the Internet, or the like. Theuser devices (402, 404) may communicate with the network (406) bywireless communication. The wireless communication may use any ofplurality of communication standards, protocols and technologies,including but not limited to, Global System for Mobile Communications(GSM), Enhanced Data GSM Environment (EDGE), high-speed downlink packetaccess (HSDPA), high-speed uplink packet access (HSUPA), Evolution,Data-Only (EV-DO), HSPA, HSPA+, Dual-Cell HSPA (DC-HSPDA), long termevolution (LTE), near field communication (NFC), wideband code divisionmultiple access (W-CDMA), code division multiple access (CDMA), timedivision multiple access (TDMA), Bluetooth, Wireless Fidelity (WiFi)(e.g., IEEE 802.11a, IEEE 802.11b, IEEE 802.11g and/or IEEE 802.11n),voice over Internet Protocol (VoIP), Wi-MAX, a protocol for e-mail(e.g., Internet message access protocol (IMAP) and/or post officeprotocol (POP)), instant messaging (e.g., extensible messaging andpresence protocol (XMPP), Session Initiation Protocol for InstantMessaging and Presence Leveraging Extensions (SIMPLE), Instant Messagingand Presence Service (IMPS)), and/or Short Message Service (SMS), or anyother suitable communication protocol. In some variations, the userdevices (402, 404) may directly communicate with each other withouttransmitting data through the network (406) (e.g., through NFC,Bluetooth, WiFi, and the like.)

The server system (408) may include a server, storage devices (includingcloud based storage), databases, and the like and can be used inconjunction with the user devices (402, 404) to transmit data. Forexample, in variations in which one of the user devices (402) is one ofthe analyte measurement devices (300) depicted in FIGS. 3A-3B, the userdevice (402) may receive information from a user, optionally process theinformation, transmit some or all of the entered and/or processedinformation to the server system (408), receive information from theserver system (408), and output an auditory, visual, or tactile promptfrom the device (402). The user device (402) may optionally transmitinformation to the second user device (404) which may also output anauditory, visual, or tactile prompt. In some embodiments, both userdevices (402, 404) may receive information from the server system (408),and output an auditory, visual, or tactile prompt. In some variations,the server system (408) may process and/or store the information. Insome instances, the user device (402) may receive and processinformation without the server system (408) and/or the network (406) andmay transmit information about an auditory, visual, or tactile prompt tothe server system (408) to transmit to the second user device (404),which may receive the information and output an auditory, visual, ortactile prompt. Any type of information can be transmitted and theserver system (408) and the user devices (402, 404) may transmitinformation through the network (406) as many times as necessary.

For the purposes of this application, a specific output and any data orsignal corresponding thereto will be referred to as a “prompt.”Likewise, for the purposes of this application, a specific user inputand any data or signal corresponding thereto will be referred to as a“command.” For example, a specific sound output and any data or audiosignals corresponding thereto will be referred to as an “auditoryprompt,” a specific visual output and any data corresponding theretowill be referred to as a “visual prompt,” and a specific auditory inputand any data or audio signals corresponding thereto will be referred toas an “auditory command.”

An auditory prompt may include speech, music, sounds, combinationsthereof, and the like, such as will be described in more detail below.In some instances, the analyte measurement device may be configured toproduce auditory prompts that can audibly guide users through one ormore operations of the device. For example, in variations where theanalyte measurement device is an integrated device, the analytemeasurement device may be configured to audibly guide a user through anentire sampling process to obtain and analyze a fluid sample todetermine a concentration or other measurement of a target analyte. Asan example, some variations of the analyte measurement devices describedhere may audibly inform a user that the device has been woken from asleep/powered off state, that the device is ready to acquire a sample,that the device is acquiring a sample, that a sample has been acquired(or in some instances, that an additional sample needs to be applied tothe device), and that the sample is being analyzed. The analytemeasurement device may then present the results of the analysis (e.g., aconcentration of blood glucose in the sample).

A visual prompt may include text, graphics, symbols, or combinationsthereof, and the like, such as will be described in more detail below.Similarly to the audible prompts discussed above, in some instances theanalyte measurement device may be configured to produce visual promptsthat can visually guide a user through one or more operations of thedevice or otherwise convey information about a user's testing history orresults.

An auditory command may include speech or sounds, or a combinationthereof, and the like, such as will be described in more detail below. Auser may use auditory commands to instruct the analyte measurementdevice to perform specified tasks.

Prompts

Typically, analyte monitors (such as glucose monitors) visuallycommunicate information to a user (e.g., via a display). For example,the analyte monitors may visually display a concentration of an analytein a sample (e.g., a glucose reading), or may visually display promptsthat instruct the user to take one or more actions associated with ananalyte measurement operation (e.g., insert a test strip or other testmedia, apply a sample to the test media, wait for analysis). This typeof visual communication normally consists of simple text appearing onthe display. The analyte measurement devices described here may beconfigured to provide information visually and/or audibly to a user(e.g., via the display (318) or the speaker (302) of the device (300)shown in FIG. 3A) in a customized manner. Generally, presentinginformation audibly may promote or otherwise facilitate the use of theanalyte measurement devices by users with vision problems, as auditoryprompts may allow a vision-impaired user to perform actions with thedevice (e.g., to complete the analysis of an analyte) without needingassistance from another user. Additionally, presenting information(visually, audibly, or otherwise) in a customized manner, as will bediscussed in more detail below, may provide a more enjoyable userexperience and may therefore increase user compliance (e.g., whether theuser tests as directed).

Generally, the analyte measurement devices described here may beconfigured to output one or more prompts during use of the device.Typically, a prompt may be outputted in response to an action taken by auser or on a scheduled basis. For example, in some variations an analytemeasurement device may provide a prompt when the device is powered on orotherwise awoken from a low-power sleep state. The prompt may provide agreeting, may inform a user of the current time, or the like. When auser initiates an analyte measurement operation (e.g., a testingsequence), the analyte measurement device may output one or more promptsthat may guide the user through one or more steps of the analytemeasurement operation. For example, a prompt may instruct a user toinsert a test strip into the device, to place a sampling site such as afinger on a test port, to apply or reapply a sample to a test port,combinations thereof and the like. Prompts may also instruct a user asto the status of the analyte measurement operation (e.g., a prompt mayinform a user that the device is obtaining a sample or is analyzing thesample) or the results of the analyte measurement operation (e.g., theconcentration of a given analyte in the sample). The analyte measurementdevices may also be configured to output multiple prompts at the sametime. For example, the analyte measurement devices may be configured tooutput both an auditory prompt and a visual prompt in response to asingle action taken by a user or on a scheduled basis.

Turning to FIGS. 5A-5B, in some variations, one or more prompts (502)may be dependent on a specific time, date, measurement, or use of thedevice (500). The analyte measurement device (500) may be configured toreceive, compile, store, and/or access data, as is described above inmore detail. In some variations, the analyte measurement device (500)may incorporate this data in the given prompts (502). FIG. 5A depicts anexample of a variation of the devices (500) described here outputting aprompt (502) that may be dependent on the time of day. As seen there,the device (500) may be configured to recognize the time of day (e.g.,morning) and to output a prompt or prompts (502) that correlate with it(e.g., a rising sun, “good morning”). The device (500) may be configuredto recognize any time of day (e.g., lunch time, evening, night, hoursduring which the user is at work, hours at which the user is sleeping,etc.) and may output prompts that correlate with the recognized time. Inother variations, a device may output a prompt (502) on certain days ofthe week (e.g., “Happy Friday,” graphic of calendar with day of week ordate), or certain days of the year (e.g., “Happy birthday!”, graphic ofbirthday cake, display age with balloons). In some instances, a prompt(502) may be dependent on the user's testing frequency. For example, asdescribed above in more detail, the analyte measurement device (500) maybe configured to record the number of analyte measurement operationsperformed by a user during a given span of time and the correspondingresults, and create a data set that can later be referenced by thedevice. The analyte measurement device (500) may be configured to outputa prompt (502) that provides the user with information about his/hertesting history and results. For example, the analyte measurement device(500) may output a prompt (502) that informs a user of his/hercompliance with an expected testing regimen (or lack thereof), thatencourages the user to better comply with the regimen, that informs auser of how many tests he/she has completed (consecutively, this week,total, etc.), and the like.

For example, if a user is complying with the expected testing regimen(e.g., consecutively or consistently testing at prescribed times), theprompt (502) may praise the user (e.g., “You're doing great! Keep itup!”, “Way to go! You've tested 4 days in a row!”, a graphic of a medalwith a numerical indication of compliance, graphic of a check mark,etc.). Conversely, if the user is not complying with the expectedtesting regiment, the prompt (502) may inform the user of this (“Youhaven't been testing 2 times a day as prescribed by Dr. Simmons. Maybeyou should test more often”, graphic of a sick patient, graphic of an“X”, etc.).

Similarly, the prompts (502) may depend on the results of one or moreanalyte measurement operations, as is depicted in FIG. 5B. For example,if a concentration or the concentrations measured during the analytemeasurement operations is consistently within a prescribed range (e.g.,for three consecutive tests, two out of three consecutive tests, or thelike), the prompt (502) may praise the user (e.g., “Your results lookgreat”, graphic of a smiley face, etc.). If a concentration or theconcentrations measured is consistently outside of a prescribed range(e.g., for three consecutive tests, two out of three consecutive tests,or the like), the prompt (502) may encourage the user to test morefrequently, to consult a physician or to change the user's diet (e.g.,“You may want to test more often,” “You may want to speak to Dr. Simmonsabout your test regimen”, a graphic of a doctor on the telephone, agraphic of a piece of candy, etc.). If a user consistently tests atcertain times throughout the day and the user fails to test at a timepreviously identified as a regular testing time, the prompt (502) mayremind the user to test (“Did you forget to test today?”, graphic of ananalyte measurement device flashing on the display with a question mark,etc.). If the time a user tests is consistently outside of a prescribedor historically calculated range, the prompt (502) may remind the userto test before the prescribed or historically calculated range passes(e.g., “Don't forget to test at 2 pm”, graphic of a set clock and anexclamation mark, etc.).

Moreover, one or more of the prompts (502) may depend on the results ofa determination of when a glucose event may occur, as is discussed indetail above. For example, a prompt (502) may inform a user of thelikelihood of a glucose event occurring (e.g., “80%”, graphic of apartially filled thermometer with a scale from 1-100%, etc.). In somevariations, the prompt (502) may inform a user that a glucose event mayoccur imminently (e.g., “You may begin to feel dizzy”, a graphic of ahospital, etc.) and/or that immediate action is required (e.g., “Pleasetest immediately”, “Please eat carbohydrates”, a graphic of a usertesting, a graphic of a suggested food, etc.). In some variations, theprompt (502) may inform a user that a potentially glucose event mayoccur in the future (e.g., “You may have low blood sugar in 2 hours”,“graphic of clock with an exclamation point, etc.) and/or suggest anaction the user may wish to take in the future (e.g., “Please test againin 1 hour”, “Please eat a snack in 30 minutes”, a graphic of a clockwith an analyte testing device, etc.).

While the prompts (502) are described as being output to/on the analytemeasurement device (500) itself, in some variations, the prompts may beoutput on a separate device (504) in communication with the analytemeasurement device, as is described above in detail with respect to FIG.4. For example, a user may interact with an analyte measurement device(500) in some capacity (e.g., turn the device on, turn the device off,begin a test sequence, finish a test sequence, etc.) and a prompt (502)may be output on one or more separate devices (504) (e.g., a cellularphone, computer, tablet, etc.). In some variations, a prompt (502) maybe output on a separate device (504) that is used or can be accessed byanother person (e.g., a computer at the user's doctor's office, acellular phone of a relative or caretaker, etc.). In other variations, aprompt (502) may be output on a separate device (504) that is used orcan be accessed by the user (e.g., the user's cellular phone, the user'scomputer, the user's headphones (for audible prompts) etc.). In someembodiments, a prompt (502) may be output on both the analytemeasurement device (500) and a separate device (504), as is depicted inFIG. 5A. Additionally, in some embodiments, the analyte measurementdevice (500) may be in communication with applications that are runningon or are stored on a separate device (504), and may be able to receiveand/or send data to/from the applications on the separate device (504).For example, in an embodiment in which a prompt (502) may be output toinform the user that a glucose event may occur now or in the future, theanalyte measurement device (500) may communicate with an alarm clockapplication running or stored on a separate device (504) and may programthe alarm clock to sound at a later time to output the prompt (502).

Commands

Generally, the analyte measurement devices described here may beconfigured to receive one or more commands during use of the device.Typically, a command may be given by a user and received by the device.For example, in some variations, a user may give a command after thedevice is powered on or otherwise awoken from a low-power sleep state.The command may provide instructions to the device or may otherwisecommunicate an action the user desires the device complete. For example,a user may provide an audible command (e.g., “Wake-up”, “Turn-off”,“Begin Test”, etc.), the device may receive the audible command, and thedevice may respond by completing the user's desired instruction (e.g.,waking-up from low-power sleep state, turning-off, beginning a testsequence, etc.). In some variations, the user may provide an audiblecommand requesting information about the user and/or his/her current orhistorical test results (e.g., “What is my blood sugar?”, “What was myblood sugar on Tuesday?”), the device may receive the command, accessthe requested information, and respond with a prompt comprising theinformation requested by the user. In some embodiments, the requestedinformation may comprise information about the status of the testingsequence or any other information that may be of interest to a user.

Auditory Prompts

As mentioned above, the analyte measurement device may output anauditory prompt in response to an action taken by the user (e.g.starting a test sequence) or on a scheduled basis (e.g. a reminder totest at a certain time every day). Auditory prompts may also be used toread on-screen menus and options, to guide a user through setting orchanging one or more options (e.g., setting a device clock, setting analarm or reminder, controlling a vacuum pump or display backlight).Table 1 below provides a plurality of examples of auditory prompts thatmay be outputted by the analyte measurement devices described here.

TABLE 1 Auditory prompt Possible Triggering Action Examples Auditoryprompt configured to Device is powered on/awoken “Welcome to POGO ®”alert user that device is in an from low-power sleep state “Goodmorning, Jane” operational state and/or provide “The time is 3:21 pm” agreeting “The device is ready for use” Auditory prompt to instruct Useractivates a analyte “Please apply your user to position a sampling sitemeasurement operation finger to the test port” (e.g., a finger) relativeto a sample acquisition portion of the device (e.g., a test port)Auditory prompt to indicate The analyte measurement “Prepare forsampling: 3. 2. 1.” that sampling or lancing will device determines thatthe occur (e.g., the device will sampling site is positioned penetratethe skin and/or relative to a sample acquisition extract a sample)portion Auditory prompt to instruct The analyte measurement “POGO ® isobtaining a user to maintain sampling site device has pierced or sample,please hold your finger position and/or provide status lanced thesampling site on the test port.” of sampling Auditory prompt to alert auser The analyte measurement “Sample Acquired.” that a usable sample hasbeen device determines that acquired. a sample has been acquiredAuditory prompt to alert a user The analyte measurement “Please applyadditional to apply additional sample to device determines that asample.” the device (e.g., if the device sufficient sample size has notdetermines that an insufficient yet been acquired volume of fluid hasbeen captured by the device) Auditory prompt to alert a user The analytemeasurement “Your blood glucose is 126 that a result has been obtaineddevice has completed an mg/mmol.” and/or measured values analytemeasurement operation

Visual Prompts

Also as mentioned above, the analyte measurement device may output avisual prompt in response to an action taken by the user (e.g. startinga test sequence) or on a scheduled basis (e.g. a reminder to test at acertain time every day). Visual prompts may also be used to guide a userthrough a test sequence (as is described above in Table 1 with respectto auditory prompts). Visual prompts that guide a user through a testsequence may comprise any visual representation of the steps of the testsequence. For example, simple text may appear on a display explainingwhat the user should do or a graphical representation of the steps mayappear (e.g., a graphic of a finger applied to the test port when a usershould apply his/her finger to the test port).

Other types of visual prompts are also contemplated. In some embodimentsa light source (e.g., LED) may illuminate a component of the device. Forexample, a component (the display, a bezel of the display, the testport, the buttons, etc.) may flash or change colors. In someembodiments, the color the component is illuminated may vary based on auser's testing history. For example, if a user has not missed any testsin his/her expected testing regimen, the component may illuminate green.If a user has missed between 0 tests and a selected set-point (e.g. 3tests, 4 tests, etc.), the component may illuminate yellow. If a userhas missed more than a selected set-point of tests, the component mayilluminate red. Illumination of the component may be tied to any of anumber of variables (e.g., missed tests as described above, time sincelast test, etc.), and any appropriate set-point (e.g., 3 tests, 3 dayssince last test, etc.). The set-point may be pre-programed into thedevice, input by the user, input by a doctor, or received by the devicefrom an external source. The component may also begin to flash or pulsebased on a user's testing history or it may both be illuminated aspecified color and flash or pulse.

In some embodiments, visual prompts may be utilized to convey data abouta user's testing patterns, trends, and/or results. For example, in someinstances, a visual prompt may comprise a graphic that may move orotherwise change positions based on a specified variable (e.g., time,testing frequency, testing consistency, amount of sample received,status of analyte measuring operation, etc.). For example, a graphic maybe displaced along the x-axis, the y-axis, or both the x and y axesconsecutively or concurrently to convey a change in a specifiedvariable. In some embodiments, a graphic may rotate to indicate a changein a specified variable, or its size or depicted volume may increase ordecrease. In other embodiments, a graphic's movement may comprise acombination of displacement, rotation, and volumetric changes.

In some variations, the graphic may change based on the cumulativeresults of many tests (e.g., number of tests completed in a specifictime frame, number of tests with results within a desired range, numberof tests completed consecutively, number of days with completed testswithin desired range, etc.). For example, each time a user finishes atest, the graphic may be modified to reflect the cumulative result ofall of the completed tests. In some instances, the graphic may bemodified such that it moves from a first pre-test position to a secondpost-test position. The movement of the graphic from the first pre-testposition to the second post-test position may convey information to theuser about the user's testing patterns or results. For example, FIG. 6Ais an illustrative example of an analyte measurement device (600)outputting such a visual prompt (602). The visual prompt (602) comprisesa mountain (608) with a hiker depicted in a first position (604) and asecond position (606). In this example, the mountain (608) may be agraphical representation of the number of tests a user must completeduring a set time frame (e.g. 1 day, 2 weeks, etc.) to be fullycompliant with the user's regimen. The hiker in the first position (604)may graphically indicate how many tests the user has completed thus farduring the set time frame and may appear before a user begins a testsequence. After the user completes the test sequence, the hiker in thesecond position (606) may appear to indicate to the user that he/she iscloser to completing all of the tests necessary to be compliant duringthe set time frame. In some embodiments, the hiker's displacement fromthe first position to the second position may appear on the screen suchthat the hiker appears to be moving. Additionally, it should beappreciated that while the hiker is moving in both the x-axis and they-axis, the graphics may be configured to move in any direction or torotate. The graphics may also be configured to move along a rotationalpath. In some embodiments, the graphic may only move horizontally andvertically and may not rotate, while in other embodiments the graphicsmay rotate and move in any direction (e.g. along a linear path,rotational path, a zig-zag path, etc.).

In some instances, the graphic may change based on data collected duringa single test (e.g., time since test sequence began, number of steps oftest sequence completed/remaining, amount of sample collected, etc.).For example, the device may output an active visual prompt as thegraphic may change in real-time while the analyte measurement device iscompleting an analyte measurement operation. As an example, the activevisual prompt may comprise a cat drinking water from a bowl andexpanding in volume while the device collects a sample from a user. Thecat's volume may be indicative of the amount of sample the device hascollected and the cat may finish drinking water and move away from thebowl when the device collects a sufficient sample volume. Anotherexample of an active visual prompt (614) is depicted in FIG. 6B. Thevisual prompt (614) may comprise a graphic that moves along a specifiedtrajectory as an analyte measurement operation is occurring.Specifically, the graphic may be at the beginning of its specifiedtrajectory or path when the user begins the analyte measurementoperation, it may be displaced such that it is at the midpoint of itsspecified trajectory when the analyte measurement operation is half-waycompleted, and it may be displaced such that it is at the end of itsspecified trajectory when the analyte measurement operation is complete.For example, FIG. 6B depicts a racecar (612) exiting a ramp (610) andcompleting a rotation in the air. In this example, the racecar (612) mayappear on the device (600) when a user begins a testing sequence. Theracecar (612) may move vertically and horizontally along a specifiedtrajectory while the testing sequence is taking place such that theracecar's (612) movement tracks the progress of the testing sequence.For example, the racecar (612) may begin exiting the ramp (610) when theuser begins the test sequence, the racecar (612) may have rotated 180degrees when the user is half-way through the test sequence, and theracecar (612) may appear to be landing when the test sequence iscomplete. The above embodiments are merely examples and any suitablegraphical representation could be used.

Customization

As discussed above, the analyte sampling devices may be configured tooutput a plurality of different prompts. In some variations, thespecific prompts outputted by the analyte measurement devices may becustomized in one or more ways. Generally, the analyte measurementdevice is programmed with a plurality of “prompt types.” Each prompttype indicates an instance during which the analyte measurement devicemay output a prompt. For example, an analyte measurement device may beconfigured with a first prompt type (e.g., providing a prompt when thedevice is powered on or awoken from a low-power sleep state), a secondprompt type (e.g., providing a prompt when a user has performed a givennumber of consecutive tests in a given time frame), and a third prompttype (e.g., providing a prompt when the device has completed an analytemeasurement operation). For each prompt type, the analyte measurementdevice may be programmed with one or more prompts that may be selectedfor that prompt type. The analyte measurement device may be figured toselect a prompt for each prompt type, and these selections arecollectively referred to as a prompt set. It may be possible for a useror the device to select from one of a plurality of possible prompt sets,and the currently selected prompt set is referred to here as the activeprompt set. The active prompt set may be manually set by a user, or maybe automatically determined by the analyte measurement device, as willbe discussed in more detail below. While typically a single prompt isselected for each prompt type of a prompt set, in some instances aplurality of different prompts may be selected for a given prompt typein a prompt set. In these instances, when the analyte measurement devicedetermines that conditions for outputting the prompt type have been met,the device may select one of the plurality of different prompts in arandom or predetermined order. Additionally, for the purposes of thisapplication, when a specific prompt of a prompt type is intended toconvey a measurement or time (e.g., a concentration of an analyte in asample, the duration of time that has passed between measurements, thenumber of consecutive days the device has performed a testing operation,the current time, etc.), the prompt is considered a single prompt eventhough the actual measurement or time conveyed by the prompt may varydepending between instances that the prompt is output.

When two or more prompts are used for a given prompt type, the promptsmay vary in any suitable manner. In some variations, a prompt type mayhave auditory prompt variations where different language is used (e.g.,“Welcome to POGO®” in a first variation, “Let's test your glucose!” in asecond variation). In other variations, a prompt type may have visualprompt variations where different graphics are used (e.g., a sun-risingin a first variation, a bowl of cereal in a second variation). In someembodiments, a prompt type may have an auditory prompt, a visual promptand a tactile prompt associated with it. In embodiments in whichmultiple prompts (e.g., visual, auditory, tactile) are associated with aprompt type, and the prompt type comprises prompt variations (e.g., 2different visual prompts, 2 different auditory prompts), any combinationof the prompts may be used and the combinations may be selected in anysuitable manner (e.g. by the user, at random, etc.).

Specifically with respect to auditory prompts, a prompt may havevariations where different voices are used (e.g., a female voice in afirst variation and a male voice in a second variation). Additionally oralternatively, a prompt may have variations where different soundeffects are associated with a prompt (e.g., when a prompt gives positivereinforcement for frequent testing, such as “Way to go! You've tested 4days in a row,” a first variation may include the sounds of a cheeringcrowd while a second variation may include a fanfare of trumpets).

In some variations, the device may be configured to allow a user torecord one or more auditory prompts. For example, when an analytemeasurement device will be used by a child, it may be desirable for thedevice to output auditory prompts that have been recorded by a parent orcaretaker of the child. Providing auditory prompts with a familiar voicemay provide an added level of comfort to the child as he or she uses thedevice, which may reduce fear associated with the device and mayencourage the child to test more frequently. The recorded auditoryprompts may be provided to the analyte measurement device in anysuitable manner. In some variations, the auditory prompts may berecorded by the user on an external device (e.g., a computer, phone,tablet, recorder, or the like), and may be transmitted to the analytemeasurement device (e.g., using a physical connection such as a USBconnection and/or a wireless connection such as WiFi or RFID, asdiscussed in more detail above). In these variations, the externaldevice may comprise a program that has a prompt recording modeconfigured to facilitate recording of specific auditory prompts, as willbe discussed in more detail below.

In other variations, the analyte measurement device may be configured torecord one or more auditory prompts. In these variations, the analytemeasurement device may comprise a microphone or other sound recordingdevice configured to capture a user's voice. Additionally, the analytemeasurement device may be programmed with a prompt recording mode. Whenthe device is placed in the prompt recording mode, the device may beconfigured to guide the user through recording one or more voiceprompts. The prompt recording mode may be initiated during initial setupof the analyte measurement device, or may be selectively initiated by auser (e.g., through a menu command). The analyte measurement device maybe configured to automatically guide the user through recording apredetermined number of auditory prompts (such as, for example, a givenprompt set), or the user may select which auditory prompts he or shewould like to record. For each auditory prompt that will be recorded inthe prompt recording mode, the analyte measurement device may beconfigured to identify what prompt or prompt type will be recorded(e.g., “Please say a few words of encouragement”, “Please repeat thefollowing when instructed: ‘Good morning!’”), instruct the user when tostart and/or stop recording (e.g., “Please begin recording after thecountdown, and press the power button when you have finished. 3, 2,1.”). When the auditory prompt has been recorded, the prompt recordingmode may be configured to associate the recorded prompt with one or moreprompt types (and in some instances, one or more prompt sets).

In some variations where an analyte measurement device may be used bymultiple users, the device may be configured to select a differentactive prompt set for different users of the device. For example, one ormore prompt types may include one or more prompts that are customized toa specific user. For example, when a prompt type is configured toprovide an analyte measurement value, an active prompt set for a firstuser may output a first variation of an auditory prompt (e.g., “John,your blood glucose is 85 mg/mmol”) or a visual prompt (e.g., a cheeringman), while an active prompt set for a second user may output a secondvariation of an auditory prompt (e.g., “Sally, your blood glucose is 85mg/mmol”) or a visual prompt (e.g., a cheering woman). In somevariations, prompts may be tailored to a given user, and may useinformation about that user (e.g., by using the user's name, the name ofthe user's physician, etc.). Additionally or alternatively, the promptsmay be selected by the user based on his/her preferences (e.g., someusers may prefer a male voice while other users may prefer a femalevoice). In some variations, prompts may be tailored to a given userusing information from a user profile setup by the user, as wasdiscussed above.

Generally, the analyte measurement device may be configured to store auser-specific prompt set for a plurality of individual users. When thedevice determines that one of the plurality of individual users is usingthe device, the device may be configured to automatically set theuser-specific prompt set associated with that user as the active promptset. In some variations, the analyte measurement device may beconfigured to select or load a specific prompt set based on informationstored in a user's user profile. If the device is being used by anunrecognized user, the device may be configured to set a default promptset as the active prompt set. Individual users may change theiruser-specific prompt set (e.g., using menu features or changing it intheir user profiles), and new users may be added to the plurality ofindividual users. The analyte measurement device may be configured todifferentiate between users in any suitable manner. In some variations,users may log into or otherwise input an identification code to theanalyte measurement device to access or indicate to the device to accesstheir user profiles. In some of these variations, a user may be requiredto log-in before the device may be used in an analyte measurementoperation. Additionally or alternatively, a user may insert a USB stick,memory card, or the like into the analyte measurement device and thedevice may determine the user's identity from this component.Additionally or alternatively, a user may carry a key fob or otherexternal device that may be wirelessly detected by the analytemeasurement device to determine the user.

Removable or Additional Components

In some variations, the analyte measurement device may select an activeprompt set (or a default active prompt set) based on one or morecomponents of the device. In some instances, an analyte measurementdevice may be constructed and/or manufactured such the analytemeasurement device may have one of a plurality of different physicalappearances. For example, when the analyte measurement device comprisesan outer housing (such as the meter housing (118) of the meter (100)discussed above with respect to FIG. 1B), the outer housing may bealtered to change the physical appearance of the analyte measurementdevice. For example, the surface contours and/or the colors of the outerhousing may alter the physical appearance of the analyte measurementdevice. Similarly, an outer housing may be configured with one or morevisual patterns (e.g., chevron pattern, polka dots, etc.) and/or images(e.g., an animal, a race car, or the like).

Accordingly, in some variations, an analyte measurement device may beconstructed and/or manufactured in one of a plurality of differentconfigurations, in which each configuration has a different physicalappearance. In some of these variations, each configuration of theanalyte measurement device may have a default active prompt setassociated with that configuration. Accordingly, systems and kits mayinclude a plurality of analyte measurement devices having differentphysical appearances, each having an appearance-specific default activeprompt set. In some instances, the default active prompt set for a givenconfiguration of the device may be thematically associated with thephysical appearance of the analyte measurement device. For example, oneor more portions of the housing of one configuration of an analytemeasurement device may include an image of a car, and the associatedauditory prompt set may include car-related sound effects (e.g., revvingengines, squealing tires) and/or speech (e.g., “Start your engines”)and/or the associated visual prompt set may include car-related visualeffects (e.g. driver in car turning key, rotating tires). Anotherconfiguration may include an image of a cat, and the associated auditoryprompt set may include cat-related sound effects (e.g., purring,meowing) and/or speech (e.g., “That test was purr-fect”) and/or theassociated visual prompt set may include cat-related visual effects(e.g., person petting cat, cat appearing to speak). The analytemeasurement devices may have any suitable number of differentconfigurations, each having a graphic appearance and an associated setof prompts.

In some variations, a user may replace one or more components of theanalyte measurement device and/or add one or more additional componentsto alter the physical appearance of the device. In some variations, theanalyte measurement device may be configured to change the active promptset in response to the replacement or addition of one of thesecomponents. In some instances, a portion of a housing of the analytemeasurement device may be releasably attached to the analyte measurementdevice such that the releasable portion may be replaced with anothervariation of the releasable portion. In other variations, the housingmay be configured to accept an additional component using snap fitconnectors, sliding connectors, clips, or the like. Systems or kits mayinclude a single removable housing portion or they may include aplurality of removable housing portions. In systems or kits that includea plurality of removable housing portions, the analyte measurementdevice may be configured such that one of the plurality of removablehousing portions may be connected to the analyte measurement device at atime. The plurality of removable housing portions may have differentphysical appearances, such as described above, such that changing theremovable housing portion of the analyte measurement device may changethe appearance of the analyte measurement device. In some variations,changing the removable housing portion of the device may notsignificantly change the physical appearance of the device, but maystill change the active prompt set. In some instances, the removable oradditional housing portion may allow for the delivery of data to thedevice, for example, updated software or firmware.

In some embodiments, the removable portion of the housing may be a frontcover of the housing. For example, in the variation of the device shownin FIG. 1B, the meter housing (118) may comprise a removable front cover(132). In other variations, a front cover may be added to the housing.For example, in the variation of the analyte measurement device (700)shown in FIG. 7A, the housing (702) may comprise a first front cover(704) and may be configured to accept a second front cover (706). Thesecond front cover (706) may alter the physical appearance of thedevice, change the active prompt set and/or deliver data stored withinit to the device. In other embodiments, the removable portion of thehousing may be a component other than the front cover. For example, asshown in FIGS. 7A and 7B, the removable portion of the housing maycomprise the bottom (708), the port (710), the battery cover (712), theback cover (714), and the like.

In some embodiments, the cartridge may be configured to carryinformation relating to a prompt set. The cartridge (102) may comprisean information storage member (134) that carries information and maycommunicate with the meter (100) to convey the stored information. Forexample, the storage information member (134) may comprise one or morebarcodes, as depicted in FIG. 1C. In these variations, the meter (100)may comprise one or more barcode scanners/readers. In variations wherethe cartridges are cylindrical or have an otherwise roundedcross-sectional area, the cartridge may be rotated to facilitate thereading of the barcode. In other instances, the meter (100) may beconfigured to move the cartridge into a position where the barcode maybe read.

The cartridge may comprise any suitable number of barcodes (e.g., zero,one, two, three, or four or more barcodes). In some variations, theinformation storage member (134) may comprise one or more memory chipsor cards, which may convey information to the meter through, forexample, RF transmission, optical communication, or via directelectrical communication. In other variations, a separate memory card orchip may be packaged and/or provided with the cartridge. This memorycard or chip may be inserted into a portion of the meter to conveyinformation to the meter, as is discussed in more detail below.

As mentioned above, the analyte measurement device may be configured tochange the active prompt set based on the removable portion that iscurrently connected to the analyte measurement device. In somevariations, the analyte measurement device may be configured toautomatically detect which removable portion is connected to the deviceand select an active prompt set associated with that removable portion.In some embodiments, the removable portion may comprise an identifierthat may contain or transmit information or otherwise communicate withthe analyte measurement device about the removable component connectedto it and/or the prompt set (e.g., auditory, visual, etc.) associatedwith the connected removable component. For example, a system maycomprise an analyte measurement device configured to receive a removablehousing portion, and may further comprise a first version of theremovable housing portion and a second version of the removable housingportion. The first version of the removable housing portion may have afirst prompt set associated therewith, and the second version of theremovable housing portion may have a second prompt set associatedtherewith. When the first version of the removable housing portion isattached to the analyte monitor, the analyte measurement device may beconfigured to detect the first version's identifier and set the firstprompt set as the active prompt set. A user may remove the first versionof the removable housing portion and connect the second version of theremovable housing portion to the analyte measurement device. Uponconnection of the second version of the removable housing portion, theanalyte measurement device may detect the second version's identifierand may set the second prompt set as the active prompt set. In somevariations, the identifier may be integrally formed with the prompt set.

Systems and kits may include a single removable housing portion or aplurality of versions of a given removable housing portion. Each versionof the plurality of versions may have an associated identifier andprompt set, and the analyte measurement device may be configured todetect the version of the removable housing portion and set theassociated prompt set as the active prompt set. In some variations, eachversion of the removable housing portion may include a different promptset. A first prompt set may be considered different from a second promptset if at least one prompt within the prompt set is different or if theprompt sets comprise different numbers of prompts.

Additionally or alternatively, as depicted in FIGS. 8A-8B, a skin (802)(e.g. a silicone case or the like) may be placed over and connected to aportion of the housing (804) of an analyte measurement device (800),which may change the physical appearance of the analyte measurementdevice (800). In these variations, the analyte measurement device (800)may be configured to detect the presence of an identifier in/on the skin(802), and may be configured to set a prompt set (auditory, visual,etc.) associated with the skin (802) as the active prompt set. In someinstances, a system or kit may comprise a skin (802) comprising anidentifier that is associated with a prompt set. In other variations, asystem or kit may comprise multiple versions of a skin (802) (e.g.,having different physical appearances or configurations), wherein eachversion comprises an identifier with a prompt set associated therewith.In these variations, the analyte measurement device may be configured todetect which version of the skin (802) is connected to the device (800)using the identifier, and may set the prompt set associated with thatidentifier as the active prompt set. For example, a system may includean analyte measurement device, a first version of a skin having a firstprompt set associated therewith, and a second version of the skin havinga second prompt set associated therewith. The skins may have differentphysical appearances, such as discussed above. In these variations, whenthe first skin is attached to the analyte measurement device, theanalyte measurement device may be configured to detect the first skin'sidentifier and set the first prompt set as the active prompt set. A usermay remove the first version and connect the second version of the skinto the analyte measurement device. In these instances, the analytemeasurement device may be configured to detect the second skin'sidentifier and may set the second prompt set as the active prompt set.In some variations, the identifier may be integrally formed with theprompt set.

In variations where an analyte measurement device is configured toreceive both a removable portion of a housing and a skin, the analytemeasurement device may be configured to select the set of auditoryprompts based on either the version of the removable portion or theversion of the skin. In some of these variations, the presence of a skinmay override the presence of the removable portion, such that theanalyte measurement device is configured to set a prompt set associatedwith the skin as the active prompt set instead of a prompt setassociated with the removable portion when both the skin and theremovable portion are present. In some instances a user may be able tochange the active prompt set even when a specific version of a skin orremovable housing portion is attached to an analyte measurement device,by for example, changing a selection in a menu on the device.

The analyte measurement device may be configured to detect theidentifier of a removable housing portion and/or a skin in any suitablemanner. In some variations, a removable housing portion/skin may beconfigured to achieve direct electrical communication with a controlunit of the analyte measurement device when attached to the analytemeasurement device. For example, the removable housing portion or skinmay include an electrical interface (such as a USB interface) that mayphysically contact an electrical interface of the analyte measurementdevice, and the analyte measurement device may be able to recognize ordetermine the presence and/or identifier of the removable housingportion/skin based on this electrical connection. Additionally oralternatively, one or more portions of the removable housingportion/skin may physically press against one or more buttons of theanalyte measurement device to indicate the presence and/or identifier ofa removable housing portion/skin. Additionally or alternatively, theremovable housing portion/skin may be configured to wirelesslycommunicate with the analyte measurement device (e.g., via WiFi or RFID)such that the analyte measurement device may be configured to recognizeor determine the presence and/or identifier of a removable housingportion/skin.

When the analyte measurement device is configured to set an activeprompt set based on a prompt set corresponding to a removable housingportion's or skin's identifier, the specific prompts from the prompt setmay be retrieved from any suitable location. In some variations, theanalyte measurement device may be pre-programmed with the necessaryprompts included in the various prompt sets. For example, if a systemincludes an analyte measurement device and a plurality of versions of aremovable housing portion, each version having a corresponding promptset, the analyte measurement device may be pre-programmed with theauditory prompts of each of the corresponding prompts. Additionally oralternatively, the analyte measurement device may be configured toretrieve one or more prompts from the removable housing portion/skin. Inthese variations, the removable housing portion/skin may be configuredto store one or more prompts or prompt sets (e.g., in a memory such asflash memory or an integrated circuit), and the analyte measurementdevice may be configured to retrieve the prompts or prompt sets from theremovable housing portion/skin. In some of these variations, the analytemeasurement device may be configured to retrieve and use the promptsfrom the removable housing portion/skin without permanently storing theprompts in memory of the analyte measurement device. In othervariations, the analyte measurement device may be configured to downloadand store the prompts from the removable portion/skin. In thesevariations, the downloaded prompts may be later selected (e.g., by auser) for use even when the specific version of the removable housingportion/skin has been removed from the analyte measurement device,using, for example, a selection menu. In still other variations, promptsor prompt sets associated with versions of a removable housingportion/skin may be downloaded from an external device (e.g., acomputer, tablet, phone in communication with the analyte measurementdevice, a memory stick that may be inserted into the analyte measurementdevice, etc.) either via direct connection (such as a USB interface) orwireless connection (e.g., WiFi, RFID). In some variations, theremovable housing portion/skin may contain updated software/firmwarethat may be transferred to the device when the removable housingportion/skin communicates with the device. The software/firmware updatesmay be contained on the removable housing portion/skin in addition to,or instead of, the prompt sets.

As mentioned above, the analyte measurement device may comprise avariety of components that enable the transfer of information from aremovable housing portion/skin to the control unit of the device. FIG.7C depicts a variation of the analyte measurement devices described herewith the back cover (714) removed. In this embodiment, the analytemeasurement device (700) may comprise electrical contacts (716) locatedbelow the batteries when the device is in use. The electrical contacts(716) may be configured to mate or otherwise communicate withcorresponding electrical contacts on a removable housing portion, forexample, a battery cover (712). Alternatively or additionally, thedevice (800) may comprise one or more wireless chips (718) that maycommunicate with one or more corresponding wireless chips contained inor on a removable portion of the device. In some embodiments, the device(800) may also comprise a USB port (720) that may physically contact aUSB plug on the removable portion of the device. These components maymate with any removable or additional portion of the housing or with askin, as described above.

FIGS. 8A-8D illustrate another variation of the analyte measurementdevices described here. FIGS. 8A and 8B depict front and perspectiveviews of an analyte measurement device (800) with a skin (802) partiallycovering the housing (804). FIGS. 8C-8D depict a top perspective view ofan analyte measurement device (800) without a skin (802), and with askin partially covering the housing (804), respectively. The analytemeasurement device (800) shown here may receive information from thereplacement or addition of a skin (802). The skin (802) may comprise anysuitable means for storing and transferring information. For example,the skin (802) may comprise a chip (806) that may store information andtransfer it to the control unit of the device (800). In some variations,the skin may comprise a USB plug (808) that may physically contact a USBport (810) on the device (800). While the USB port (810) is depicted onthe top of the device (800), it may be placed at any location that issuitable for connection to a skin (802) or other removable or additionalhousing portion. In some variations, the skin (802) may comprise both aUSB plug (808) and a USB port (812) such that attachment of the skin(802) to the device (800) does not prevent the device (800) fromconnecting via USB to another component.

1. A system comprising: an analyte measurement device comprising: ahousing, wherein the housing comprises a releasable housing portion andwherein the releasable housing portion comprises an auditory identifierthat is associated with an auditory prompt set; a speaker; a controlunit, wherein the control unit is configured to detect the auditoryidentifier, set the auditory prompt set associated with the detectedauditory identifier as an active prompt set, and instruct the speaker tooutput at least one auditory prompt from the active prompt set.
 2. Thesystem of claim 1 wherein the system further comprises a plurality ofreleasable housing portions.
 3. The system of claim 2 wherein each ofthe releasable housing portions is associated with an auditory promptset comprising at least one auditory prompt that differs from at leastone auditory prompt associated with the other releasable housingportions of the plurality of releasable housing portions.
 4. The systemof claim 1 wherein the control unit comprises a processor.
 5. The systemof claim 1 wherein the control unit comprises a memory unit.
 6. Thesystem of claim 5 wherein the auditory prompt set associated with thereleasable housing portion is stored on the memory unit.
 7. The systemof claim 1 wherein the auditory prompt set associated with thereleasable housing portion is stored on the releasable housing portion.8. The system of claim 1 wherein the auditory prompt set associated withthe releasable housing portion is stored on a server.
 9. The system ofclaim 1 wherein the control system comprises a speech unit and whereininstructing the speaker to output at least one auditory prompt from theactive prompt set comprises transmitting a signal associated with the atleast one auditory prompt from the speech unit to the speaker.
 10. Thesystem of claim 1 wherein the analyte measurement device furthercomprises a display.
 11. The system of claim 1 wherein the analytemeasurement device further comprises a microphone.
 12. The system ofclaim 1 wherein the analyte measurement device is an integrated meter.13. The system of claim 1 wherein the system further comprises acartridge. 14-26. (canceled)
 27. A method for assisting a user inmeasuring an analyte using an analyte measurement device, the methodcomprising: outputting, via a speaker of the analyte measurement device,an auditory prompt that warns a user of an impending lance with a skinpenetration member by indicating an expiring time period until the lanceoccurs, and an auditory prompt that alerts the user that the analytemeasurement device has acquired a usable sample.